Graft Fixation Device

ABSTRACT

In one aspect a device is disclosed for use as a bone implant comprising, a body having a pre-implantation shape and a post-implantation shape different from the pre-implantation shape. The body is configured to change from the pre-implantation shape to the post-implantation shape in response to the body being activated. The body is configured to be inserted in a bone recess while the body is in the pre-implantation shape. In another aspect a method is disclosed comprising inserting a cable member into a recess in a bone, inserting a retention device into the recess, the retention device containing a shape memory material, and activating the shape memory material.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/667,876 filed Apr. 1, 2005, which application is hereby incorporatedherein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

The invention was sponsored by National Science Foundation Grant No.NSF-DMI-0200495 and a National Institute of Health Grant No.NIH-HL-067393 and the government has certain rights to this invention.

BACKGROUND OF THE INVENTION

Ligaments are strong fibrous soft tissue connecting the articular endsof bones to bind them together and to facilitate or limit motion.Injuries to ligaments are common, and patients who are physically activeare generally more susceptible to such ligament injuries. The anteriorcruciate ligament (ACL) of the knee joint is a ligament frequentlyinjured by such patients. ACL injuries cause instability in the kneejoint which, when left untreated, may lead to degenerative arthritis.Because of this condition, ACL reconstruction may be required. Generallyduring ACL reconstruction, a substitute soft tissue ligament or graft isattached to the femur (femoral fixation) and/or to the tibia (tibialfixation) to facilitate regrowth and permanent attachment.

There are several known methods for performing ACL reconstruction, andthere are also several tibial or femoral fixation devices that may beused with these methods.

In surgery it is generally known to use soft tissue tendon grafts (e.g.hamstring tendon, taken from the thigh of the patient) to replace theseverely damaged ACL. In a typical surgical procedure one end of a softtissue graft is fixed into a drill hole made from the knee joint intothe distal femur and another end of the graft is fixed into a drill holemade into the proximal tibia. The ends of the graft are fixed into thedrill holes with fixation screws and in most cases with so-calledinterference screws. An interference screw may be a screw that has alarger diameter (including any grafts or tendons) than the cavity, thusgenerating a force that holds the tendon. A screw is installed into thespace between the drill hole and the soft tissue grafts to lock thegrafts into the drill hole. The tendon then acts as a new ACL.

There are several known methods for performing ACL reconstruction, andthere are also several tibial or femoral fixation devices that may beused with these methods. The fixation screws, like interference screws,are normally made of metal like stainless steel or titanium, or of abio-absorbable polymer like polylactide. An interference screw may beconsidered as metallic and/or bio-absorbable polymeric materials andcomposites, which are suitable for manufacturing of tendon graftfixation screws, are well known in the art, for example as described inthe literature.

Conventional extra-articular hamstring graft fixation techniques havecomplications, such as suture stretch, graft tunnel motion and so-calledwindshield wiper effect where the size of the intra-articular drill holeend will increase due to graft movement in the drill-hole. Also the useof screws as fixation implants for soft tissue grafts in anteriorcrucial ligament procedures is complicated due to: 1) the threads of thescrew cutting the grafts during screw installation if the screw is toobig in relation to the tendon and/or if the space between the drill holeand tendon grafts is too small; 2) the threads of the screw damaging thetendon during screw installation; 3) the tendon rotating with the screwduring screw installation so that the optimal position of the grafts islost and/or the grafts are damaged; 4) divergence of the grafts and/orscrew occurring; and 5) the bio-absorbable screw breaking duringinsertion.

SUMMARY OF THE INVENTION

In one embodiment, the invention provides a fixation device, which mayfix a soft tissue graft, like a tendon or ligament graft, to a bone withlittle risk of damaging the soft tissue graft during insertion.

One aspect is a device for use as a bone implant comprising, a bodyhaving a pre-implantation shape and a post-implantation shape differentfrom the pre-implantation shape. The body is configured to change fromthe pre-implantation shape to the post-implantation shape in response tothe body being activated. The body is configured to be inserted in abone recess while the body is in the pre-implantation shape.

Another aspect is a method comprising inserting a cable member into arecess in a bone, inserting a retention device into the recess, theretention device containing a shape memory material, and activating theshape memory material.

Another aspect is a kit comprising a first bone implant. The first boneimplant has a first pre-implantation shape and a first post-implantationshape different from the first pre-implantation shape. The first boneimplant is configured to be inserted in a first bone recess while thefirst bone implant is in the first pre-implantation shape. The firstbone implant is configured to fix a cable member to the first bonerecess while the first bone implant is in the first post-implantationshape. The kit also comprises a second bone implant. The second boneimplant has a second pre-implantation shape and a secondpost-implantation shape different from the second pre-implantationshape. The second bone implant is configured to be inserted in a secondbone recess while the second bone implant is in the secondpre-implantation shape. The second bone implant is configured to fix thecable member to the second bone recess while the second bone implant isin the second post-implantation shape. The second post-implantationshape is different from the first post-implantation shape.

Another aspect is a method comprising shaping a polymer material into apost-implantation shape and deforming the polymer material into apre-implantation shape different from the post-implantation shape, whilemaintaining the temperature of the polymer material above a certaintemperature. The method also comprises cooling the polymer material tobelow the certain temperature while holding the polymer material in thepre-implantation shape.

Another aspect is a kit comprising a first solution comprising amonomer, the first solution contained in a first container, a secondsolution comprising a cross-linker, the second solution contained in asecond container. The kit also includes a cable member configured tofunction as a soft tissue replacement in a human body. The secondsolution is configured to form a third solution if the second solutionis mixed with the first solution, wherein the third solution is capableof forming a shape memory polymer upon polymerization.

Another aspect is a polymerized composition comprising, a linear chaincomprising an acrylate, a first cross-linker comprising adimethacrylate, wherein the polymerized composition exhibits a glasstransition at a temperature between about −50 degrees Celsius and about150 degrees Celsius and wherein the polymerized composition exhibitsshape memory effects.

Another aspect is a polymerized composition comprising, a firstpercentage by weight of a linear chain, and a second percentage byweight of a first cross-linker, wherein the polymerized compositionexhibits shape memory effects.

A BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a cross-section of an embodiment of an anterior cruciateligament repair site;

FIG. 2 shows a cross-section of a device installed and in apost-implantation shape with a cable member in a bone recess;

FIG. 3 shows a cross-section of another embodiment of a device installedand in a post-implantation shape with a cable member in a bone recess;

FIG. 4 shows a cross-section of another embodiment of a device installedand in a post-implantation shape with a cable member in a bone recess;

FIG. 5 shows flow-chart of a method for performing surgery;

FIG. 6 shows a flow-chart of a method of manufacturing devices;

FIGS. 7 a-7 h shows multiple forms of possible unconstrained shapes ofdevices;

FIG. 8 shows a polymer extrusion unit;

FIG. 9 a shows an embodiment of a pre-deformed or unconstrained shape;

FIG. 9 b shows and embodiment of a deformed shape or pre-implantationshape;

FIG. 10 shows different tip geometries of devices;

FIG. 11 shows experimental results of stresses of several polymercompositions;

FIG. 12 shows the free strain recovery time of devices strained and thenstored in the strained state before recovery was initiated;

FIG. 13 shows experimental results of constrained recovery time as afunction of crosslinking.

FIG. 14 shows a custom force measuring fixture;

FIG. 15 shows experimental results of the recovery load of a shapememory polymer plug;

FIG. 16 shows experimental results of the load of a prior artinterference screw;

FIG. 17 shows a test setup for an in-vitro maximum failure strength andcyclic strength of a fixation device as installed;

FIG. 18 shows experimental results comparing SMP fixation devices and aDelta Interference Screw;

FIG. 19 shows experimental results comparing tensile strengths anddisplacement ratios of the cyclic response (e.g., response to multiplecycles) of a ShapeLoc fixation device;

FIG. 20 a shows mean and standard deviations of tensile strengths ofvarious fixation devices;

FIG. 20 b shows mean and standard deviations of stiffnesses of variousfixation options;

FIG. 20 c shows mean and standard deviations of slip rates of variousfixation options;

FIG. 21 shows a tissue encapsulation setup;

FIG. 22 a shows a device in a pre-implantation shape;

FIG. 22 b shows a device in a mid-deployment shape;

FIG. 22 c shows a device in an unconstrained shape;

FIG. 23 shows a device with a polymerized solution around the device;

FIG. 24 shows a schematic of the three-point flexure thermomechanicalsetup and the results of a Dynamic Mechanical Analysis (DMA) testshowing storage modulus and tan-delta as a function of temperature forthe PEGDMA copolymer and PLA.

DETAILED DESCRIPTION OF THE INVENTION

The following description of various embodiments is merely exemplary innature and is in no way intended to limit the invention, itsapplication, or uses.

An example of a joint repair surgery in which the following polymers,devices, methods and kits may be used is the repair of an ACL in a humanknee. A ruptured ACL may be repaired through, in part, attaching a cablemember the native posterior ACL attachment site (e.g., an opening of thetunnel at the site). For example, a cable member may be attached to thesite via creating a bone recess and fixing the cable member to the bonerecess. A bone recess may be used to increase the surface area of boneto which the cable member may be fixed.

A technique in the prior art for fixation of an ACL soft tissue graftincludes drilling a properly sized tunnel from the anteromedial tibialmetaphysis into the native posterior ACL attachment site, feeding a softtissue graft into the tunnel, and fixing the soft tissue graft to thetunnel via an interference screw driven into the tunnel against the softtissue graft.

Another technique in the prior art includes drilling a tunnel in a tibiaand placing an anchor with an attached suture into the tunnel thusanchoring the suture in the bone. The suture is then attached to thesoft tissue graft.

FIG. 1 shows a cross-section of an embodiment of an anterior cruciateligament (ACL) repair site 100. The ACL repair site 100 comprises apatella 110, a femur 112, and a tibia 114. A tibia recess 116 has beencreated in the tibia 114, and a femur recess 120 has been created in thefemur 112. A cable member 102 is partially inside both the tibia recess116 and the femur recess 120. Devices 104 are inside each of the tibiarecess 116 and the femur recess 120.

A surgeon or other practitioner may insert devices 104 into either orboth of the tibia recess 116 and the femur recess 120 using an insertiondevice 106. In one embodiment, the insertion device 106 is a guide wirethat may aid in the insertion of a device 104. For example, a device 104may be threaded onto a guide wire (e.g., the guide wire enters thedevice through one opening in the device and exits through anotheropening in the device), and the device may be pushed into an installedposition along the guide wire. In another embodiment, the insertiondevice 106 is a shaft that may be used to push the device 104 intoplace. For example, a cavity in the device 104 may accept the insertiondevice 106, allowing the insertion device (e.g., shaft) to couple withthe device, guide the device and move the device into an installedposition. As another example, the device 104 may be attached to theinsertion device 106 and the device 104 and insertion device 106 may beseparated (e.g., when the device is in an installed position).

In the embodiment shown in FIG. 1, the devices 104 are substantiallysmooth and have narrow tips in the pre-implantation shape (shown). Inanother embodiment, the devices 104 have a shorter, wider shape in thepost-implantation shape (not shown).

The devices 104 shown in FIG. 1 represent one embodiment of a devicewhich may be used to repair an ACL in this manner. Numerous otherembodiments of devices and modifications to devices similar to thedevices 104 shown in FIG. 1 are described herein. For example, any ofthe embodiments described herein of devices, methods and polymers may beused to repair an ACL.

The descriptions of devices, methods and polymers herein should not beunderstood to be limited only to the Figures or to any specific Figure.Therefore, the devices shown in FIG. 1 may be used as shown in otherFigures or may otherwise be used, and the devices shown in other Figuresor otherwise described may be used in FIG. 1 or may otherwise be used.

In the embodiment shown, the cable member 102 is used to replace a tornor failed ACL. The cable member is held by the devices 104 at points(e.g., artificial attachment sites) in the tibia 114 and the femur 112.The cable member 102 may comprise any suitable material, as describedfurther herein.

An ACL repair in a knee is discussed here as an example of a surgerysite where a device and/or method of the present invention may beemployed. Other sites, joints and parts of anatomy may have surgeryperformed on them using a polymer, device or method of the presentinvention. For example, the devices and methods described herein can beused for rotator cuff reconstruction, for acromioclavicular (AC)reconstruction, for ACL reconstruction and for fastening tendons,grafts, or sutures to other tissue, such as bone or other soft tissue.

Common weaknesses with the ACL replacement methods practiced in sportsmedicine industry are caused by the fixation device and how it is used.For example, the fixation device may be the source of failure for thesurgery by allowing a cable member (e.g., tendon) to slip. The fixationdevice may also cause a cable member to break. For example, aninterference screw may cut into or entirely through the cable memberduring the process of insertion into the bone tunnel.

A cable member as used herein may be a tendon, ligament, artificial softtissue replacement, a metal wire, a composite structure, synthetic fiberor any member that may be used to create a substitute for an animal softtissue (e.g., tendon, ligament, fascia, vessel).

FIG. 2 shows a cross-section of a device 200 installed and in apost-implantation shape with a cable member 202 in a bone recess 204.The device 200 comprises a cavity 206. The device 200 presses the cablemember 202 against a wall of the bone recess 204 thereby using friction(e.g., friction between the wall and the cable member, friction betweenthe device and the cable member, friction between the device and thewall) to fix the cable member to a bone 212.

The device 200 may be inserted into the bone recess 204 in apre-implantation shape that is different from the post-implantationshape. In one embodiment, the device 200 comprises a shape memorymaterial. The shape memory material allows the device 200 to change fromthe pre-implantation shape to the post-implantation shape. For example,after the device is placed within a bone recess, the shape memorymaterial may be activated into a post-implantation shape. In anotherembodiment, the device 200 comprises an elastomer. The elastomer allowsthe device 200 to change from the pre-implantation shape to thepost-implantation shape. For example, the device 200 may be placedwithin a bone recess 204 while the is elastomer constrained by aconstraining member. The removal (e.g., separating, dissolving) of theconstraining member may allow the elastomer to change into apost-implantation shape. In yet another embodiment, another material maybe used to allow the device 200 to change from a pre-implantation shapeto a post-implantation shape.

The discussion herein of shape memory materials and devices that useshape memory materials may be understood as an example of how a devicemay be used with a pre-implantation shape and a post-implantation shapeto fix a cable member as part of a surgical procedure. The use of shapememory materials is not meant to exclude the analogous use of elastomermaterials or other appropriate materials.

The post-implantation shape may be a function of the bone recess 204 andthe cable member 202 as installed with the device. A device may alsohave an unconstrained shape that the device would embody if it wereactivated with little or no constraints on the device's shape (e.g., thedevice resting on a table, the device in a water bath, the deviceresting on a heating plate). The post-implantation shape may be afunction of the device's unconstrained shape. For example, the devicemay exert a force (e.g. stress) on a cable member and/or a bone recessbased on the difference between the post-implantation shape of thedevice and the unconstrained shape of the device (e.g., the differencemay represent the strain on the device caused by the deformation stillpresent in the device, as installed, after activation).

A device may have different post-implantation shapes based on particularinstallation. To the extent that the stress (e.g. forces transmittedfrom the bone recess 204 and the cable member 202) induce strain on thedevice, the device's post-implantation shape may be determined by theparticular installation and installation procedure of the cable memberand determined by the particular bone recess. In one embodiment, thepre-implantation shape is substantially different from the device'spost-implantation shape. In another embodiment, some elements of thedevice do not change significantly between the device's pre-implantationshape and the post-implantation shape.

As used herein the term “bone recess” may comprise any volume at leastpartially defined by a bone wall. For example, a bone recess may be ahole in a bone, a pre-existing configuration of a bone, a configurationbetween two bones, or a configuration between two boney structures. Inone embodiment, a bone recess 204 is a tunnel drilled into a bone 212.In another embodiment, a bone recess comprises a space between two bonesin a joint (not shown). For example, a bone recess within a joint mayaccept a device in a pre-implantation shape and the bone recess withinthe joint may be spread by the activation of the device into apost-implantation shape. In yet another embodiment, a bone recess is anirregular cavity in a bone (not shown). For example, a bone recess maybe a fracture in a bone or a milled shelf in a bone.

Shape memory materials may recover a predetermined shape aftermechanical deformation, exhibiting a shape memory effect. A shape memoryeffect is often initiated by a change in temperature and has beenobserved in metals, ceramics, and polymers. However, a shape memoryeffect may be initiated by another cause. From a macroscopic point ofview, the shape memory effect in polymers may differ from ceramics andmetals due to the lower stresses and larger recoverable strainssometimes achieved in polymers.

For example, a polymer is a shape memory polymer (SMP) if the originalshape (e.g., an unconstrained shape) of the polymer body may berecovered by heating the body without substantial constraints above ashape recovery temperature, a glass transition temperature, ordeformation temperature (T_(d)), even if the original shape of thepolymer has been destroyed mechanically at a lower temperature thanT_(d), or if the memorized shape (e.g., the unconstrained shape) isrecoverable by application of another stimulus. Any polymer that canrecover an original shape from a temporary shape (e.g., apre-implantation shape) by application of a stimulus such as temperaturemay be considered a SMP. The original shape is set by manufacture andthe temporary shape is set by thermo-mechanical deformation.

A SMP may have the ability to recover large deformation upon heating. Inone embodiment, a device with a memorized shape (e.g., original shape)is made from a SMP, which can subsequently be crushed or deformed andinserted into a bone recess, used to hold a graft, and the device isdeployed (e.g., expanded, contracted) by increasing the temperature ofthe device. In one embodiment, the device's deployment may be controlledby controlling the temperature of the device.

However, the shape memory effect of a shape memory material is differentfrom, and usually greater in terms of absolute effect, than the thermalexpansion of a material. Those with skill in the art will understand thedifferences and similarities between shape memory effects and thermalexpansion effects.

The thermomechanical response of shape memory polymers may be defined byfour critical temperatures. The glass transition temperature, T_(g), istypically represented by a transition in modulus-temperature space andcan be used as a reference point to normalize temperature. Shape memorypolymers offer the ability to vary T_(g) over a temperature range ofseveral hundred degrees by control of chemistry or structure. Thepre-deformation temperature, T_(d), is the temperature at which thepolymer is deformed into its temporary shape. Depending on the requiredstress level and strain level, the initial deformation at T_(d) canoccur above or below T_(g). The storage temperature, T_(s), representsthe temperature in which no shape recovery occurs. T_(s) is often equalto or below T_(d). At the recovery temperature, T_(r), the shape memoryeffect is activated, which causes the material to recover its originalshape, and is typically in the vicinity of T_(g) or above. Therefore,T_(s) is often below T_(g) because shape recovery begins at T_(r). In anembodiment, recovery may be accomplished isothermally by heating to afixed T_(r) and then holding, or by continued heating up to and pastT_(r).

Generally, a transition temperature may be a characteristic of amaterial (e.g., SMP, thermoplastic, thermoset) and may be defined in anumber of ways. For example, a transition temperature may be defined bya temperature of a material at the onset of a transition, the midpointof a transition, or the completion of a transition. As another example,a transition temperature may be defined by a temperature of a materialat which an inflection point of the modulus of a material (e.g., peaktan-delta).

A transition temperature may be represented by a glass transitiontemperature, a melting point, or another temperature related to a changein a process in a material or a characteristic of a material.

A transition temperature may be related to a number of processes orcharacteristics. For example, a transition temperature may relate to atransition from a stiff (e.g., glassy) behavior to a rubbery behavior ofa material. As another example, a transition temperature may relate to amelting of soft segments of a material.

The processes and characteristics relating to a transition temperaturemay be microscopic or macroscopic. For example, a transition temperaturemay relate to molecule mobility or microscopic material structure. Asanother example, a transition temperature may relate to the strength ofmolecular bonds As yet another example, a transition temperature mayrelate to a modulus of the material.

In addition, the microscopic processes, including those processes arounda transition temperature, may be related to the macroscopic propertiesof the material. Indeed, one method of determining whether a microscopicprocess is occurring (or has occurred) is to monitor macroscopicprocesses or characteristics. Microscopic characteristics are commonlyrelated to macroscopic characteristics, and macroscopic characteristicsare commonly monitored as a substitute for monitoring microscopiccharacteristics.

From a macroscopic viewpoint, a polymer often has a shape memory effectif it possesses a glass transition, a modulus-temperature plateau in therubbery state, and a difference between the maximum achievable strain,ε_(max), during deformation and permanent plastic strain after recovery,ε_(p). The difference ε_(max)−ε_(p) is defined as the recoverablestrain, ε_(recover), while the recovery ratio is defined asε_(recover)/ε_(max).

The microscopic mechanism responsible for shape memory in polymersdepends on both chemistry and structure. A cause of shape recovery inpolymers is the low conformational entropy state created andsubsequently frozen during the thermomechanical cycle. If the polymer isdeformed into its temporary shape at a temperature below T_(g), or at atemperature where some of the hard polymer regions are below T_(g), theninternal energy restoring forces will also contribute to shape recovery.In either case, to achieve shape memory properties, the polymer oftenhas some degree of chemical crosslinking to form a “memorable” networkor may contain a finite fraction of hard regions serving as physicalcrosslinks.

Polymers may be selected based on the desired glass transitiontemperature(s) (e.g., at least one segment is amorphous) or the meltingpoint(s) (e.g., at least one segment is crystalline), which in turn isbased on the desired applications, taking into consideration theenvironment of use. Shape memory polymers may be designed for use inmedical devices. Design decisions may depend on the targeted body systemand other device design constraints such as required in-vivo mechanicalproperties.

For example, a SMP may be designed so that the polymer transitiontemperature is near a standard human body temperature (e.g.,T_(r)˜T_(g)˜37° C.) thereby using a body's thermal energy to activatethe SMP. The mechanical properties (e.g. stiffness) of the SMP materialoften depend on T_(g). Those with skill in the art will recognize thatdesigning a stiff SMP device when the polymer T_(g) is close to astandard human body temperature may be difficult due to the compliantnature of the polymer.

In an embodiment, the required storage temperature, T_(s), of a shapememory polymer with T_(g)˜37° C. will possibly be below room temperaturerequiring “cold” storage prior to deployment. A shape memory polymer mayalso be designed so that the recovery temperature is higher than astandard human body temperature T_(r)˜T_(g)>37° C. In one embodiment,the glass transition temperature of the SMP is about 48° C. Those withskill in the art will recognize that the storage temperature may beequal to room temperature thereby facilitating storage of the device andreducing unwanted deployments. A higher recovery temperature than ˜37°C. may require localized heating of the SMP to induce recovery of theSMP. Damage to some cells in the human body may occur at temperaturesabout 5 degrees Celsius above the body temperature through a variety ofmechanisms including apoptosis and protein denaturing. Local heating“bursts” may be used to minimize exposure of human cells to elevatedtemperatures and to circumvent cell damage through over-heating.

SMPs may have biocompatibility with different areas of the body. Forexample, FDA approved dental materials may not be biocompatible in acardiovascular environment. Polyethyleneglycol (PEG), a form of which isalso known as polyethylene oxide (PEO), has been studied for its proteinand cell resistance, which renders a non-fouling surface. Polylacticacid (PLA) as well as polyglycolic acid (PLGA) have already been FDAapproved in devices such as interference screws and suture materials.However, there may be some concerns about PLA being hydrolyticallybroken down into lactic acid, which could potentially cause aninflammatory response in surrounding cells. Nonetheless, PEGcopolymerized with PLA (PEG-co-PLA) may form a cross-linked hydrogel.These hydrogels may be modified with methacrylate groups to achieve awide range of properties. PEG modified with methacrylates have shownbiocompatibility with tissue engineering. Other biodegradable polymersare polypropylene-fumarate-co-ethyleneglycol, polycaprolactone,polyanhydrides, and polyphosphazenes.

SMP polymer segments may be natural or synthetic. The polymer segmentsmay be biodegradable or non-biodegradable. Biodegradable materials maydegrade by hydrolysis, by exposure to water or enzymes underphysiological conditions, by surface erosion, by bulk erosion, or acombination thereof. Non-biodegradable polymers used for medicalapplications may not include aromatic groups other than those present innaturally occurring amino acids.

The polymer may be in the form of a hydrogel (typically absorbing up toabout 90% by weight of water). The polymer may also be ionicallycrosslinked with multivalent ions or polymers. Ionic crosslinkingbetween soft segments can be used to hold a structure, which, whendeformed, can be reformed by breaking the ionic crosslinks between thesoft segments. The polymer may also be in the form of a gel in solventsother than water or aqueous solutions. In these polymers, a temporaryshape can be fixed by hydrophilic interactions between soft segments.

Representative natural polymer blocks or polymers include proteins suchas zein, modified zein, casein, gelatin, gluten, serum albumin, andcollagen, and polysaccharides such as alginate, celluloses, dextrans,pullulane, and polyhyaluronic acid, as well as chitin,poly(3-hydroxyalkanoate)s, especially poly(.beta.-hydroxybutyrate),poly(3-hydroxyoctanoate) and poly(3-hydroxyfatty acids). Representativenatural biodegradable polymer blocks or polymers include polysaccharidessuch as alginate, dextran, cellulose, collagen, and chemical derivativesthereof (substitutions, additions of chemical groups, for example,alkyl, alkylene, hydroxylations, oxidations, and other modificationsroutinely made by those skilled in the art), and proteins such asalbumin, zein and copolymers and blends thereof, alone or in combinationwith synthetic polymers.

Representative synthetic polymer blocks or polymers includepolyphosphazenes, poly(vinyl alcohols), polyamides, polyester amides,poly(amino acid)s, synthetic poly(amino acids), polyanhydrides,polycarbdnates, polyacrylates, polyalkylenes, polyacrylamides,polyalkylene glycols, polyalkylene oxides, polyalkylene terephthalates,polyortho esters, polyvinyl ethers, polyvinyl esters, polyvinyl halides,polyvinylpyrrolidone, polyesters, polylactides, polyglycolides,polysiloxanes, polyurethanes and copolymers thereof. Examples ofsuitable polyacrylates include poly(methyl methacrylate), poly(ethylmethacrylate), poly(butyl methacrylate), poly(isobutyl methacrylate),poly(hexyl methacrylate), poly(isodecyl methacrylate), poly(laurylmethacrylate), poly(phenyl methacrylate), poly(methyl acrylate),poly(isopropyl acrylate), poly(isobutyl acrylate) and poly(octadecylacrylate).

Synthetically modified natural polymers include cellulose derivativessuch as alkyl celluloses, hydroxyalkyl celluloses, cellulose ethers,cellulose esters, nitrocelluloses, and chitosan. Examples of cellulosederivatives include methyl cellulose, ethyl cellulose, hydroxypropylcellulose, hydroxypropyl methyl cellulose, hydroxybutyl methylcellulose, cellulose acetate, cellulose propionate, cellulose acetatebutyrate, cellulose acetate phthalate, carboxymethyl cellulose,cellulose triacetate and cellulose sulfate sodium salt. These arecollectively referred to herein as “celluloses”.

Representative synthetic degradable polymer segments include polyhydroxyacids, such as polylactides, polyglycolides and copolymers thereof;poly(ethylene terephthalate); polyanhydrides, poly(hydroxybutyric acid);poly(hydroxyvaleric acid); poly[lactide-co-(.epsilon.-caprolactone)];poly[glycolide-co-(.epsilon.-caprolactone)]; polycarbonates, poly(pseudoamino acids); poly(amino acids); poly(hydroxyalkanoateis;polyanhydrides; polyortho esters; and blends and copolymers thereof.Polymers containing labile bonds, such as polyanhydrides and polyesters,are well known for their hydrolytic reactivity. Hydrolytic degradationrates of these polymers may be altered by simple changes in the polymerbackbone and the polymer's sequence structure.

Examples of non-biodegradable synthetic polymer segments includeethylene vinyl acetate, poly(meth)acrylic acid, polyamides,polyethylene, polypropylene, polystyrene, polyvinyl chloride,polyvinylphenol, and copolymers and mixtures thereof.

Hydrogels can be formed from polyethylene glycol, polyethylene oxide,polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylates, poly (ethyleneterephthalate), poly(vinyl acetate), and copolymers and blends thereof.Several polymeric blocks, for example, acrylic acid, are elastomericonly when the polymer is hydrated and hydrogels are formed. Otherpolymeric blocks, for example, methacrylic acid, are crystalline andcapable of melting even when the polymers are not hydrated.

Either type of polymeric block can be used, depending on the desiredapplication and conditions of use. For example, shape memory is observedfor acrylic acid copolymers largely in the hydrogel state, because theacrylic acid units are substantially hydrated and behave like a softelastomer with a very low glass transition temperature. The dry polymersdo not exhibit significant shape memory effects. When dry, the acrylicacid units behave as a hard plastic even above the glass transitiontemperature and show little change in mechanical properties on heating.In another example, copolymers including methyl acrylate polymericblocks as the soft segments show shape memory properties even when dry.

The polymers can be obtained from commercial sources such as SigmaChemical Co., St. Louis, Mo.; Polysciences, Warrenton, Pa.; AldrichChemical Co., Milwaukee, Wis.; Fluka, Ronkonkoma, N.Y.; and BioRad,Richmond, Calif. Alternately, the polymers can be synthesized frommonomers obtained from commercial sources.

In an embodiment, SMPs may be photopolymerized from tert-butyl acrylate(tBA) di-functional monomer with polyethylene glycol dimethacrylate(PEGDMA) tetra-functional monomer acting as a crosslinker. Adi-functional monomer may be any compound having a discrete chemicalformula further comprising an acrylate functional group that will formlinear chains. A tetra-functional monomer may be any compound comprisingtwo acrylate, or two methacrylate groups. A crosslinker may be anycompound comprising two or more functional groups (e.g., acrylate,methacrylate). Also, ethyleneglycol, diethyleneglycol, andtriethyleneglycol based acrylates are forms of polyethyleneglycol basedacrylates with one, two, or three repeat units.

A functional group may refer to any reactive group. For example, afunctional group may be an acrylate group. A mono-functional moleculerefers to a molecule having one functional group (e.g., an acrylategroup, a methacrylate group). A multi-functional molecule may have twoor more functional groups.

In one embodiment, the SMP material is a photo-initiated networkcomprising of tert-butyl acrylate (tBA), polyethyleneglycoldimethacrylate (PEGDMA), and 2,2-dimethoxy-2-phenylacetephenone as aphoto-initiator. The glass transition temperature (T_(g)) may betailored to a T_(g)˜48° C. through controlling the amount ofcross-linking PEGDMA. A T_(g) of roughly 48° C. is a useful T_(g) orshape recovery within a human body temperature.

Those with skill in the art will recognize that other polymerizationtechniques, such as thermal radical initiation, can be used for polymerfabrication.

Shape memory properties of a class of polymers with a high degree ofbiocompatibility may be investigated using a three-point flexure testingapparatus (as shown in FIG. 24) to investigate the thermomechanics ofthe shape memory effect under various conditions. The experimentalresults below form a foundation for understanding the effects ofpre-deformation temperature, constraint level, and recoverytemperature/time on the shape memory effect in a biocompatible polymersystem. The examples and embodiments described herein are meant toillustrate, not to limit, the present invention.

Other potential applications of biocompatible shape memory polymers,which capitalize on some of the observed thermomechanical behaviorsinclude rotator cuff reconstruction, for acromioclavicular (AC)reconstruction, for anterior cruciate ligament reconstruction (ACL) andgenerally for fastening tendons, grafts, or sutures to tissue, includingsoft tissue and bone.

In an alternate embodiment (not shown) the device has a substantiallycylindrical cross-section with ridges. The ridges are just an example ofshapes and shape features that may be used to aid in fixing the deviceto the bone recess and/or the cable member. For example, baffles, flaps,screw-like threads and/or bumps may be used to aid the fixation of thedevice to the bone recess and/or the cable member. The below descriptionof ridges, therefore, should be understood to apply to all types ofshapes and shape features of a device.

Ridges may be part of the device's shape in order to increase thedevice's contact surface area, for example, between the device (e.g.,200) and the cable member (e.g., 202) or between the device and the bonerecess. In one embodiment, ridges may be configured to conform to thebone recess, providing a more solid fixation force between the bonerecess and the device.

In one embodiment, the ridges may be part of the device'spre-implantation shape, In another embodiment, the ridges may be part ofthe device's post-implantation shape. In yet another embodiment, theridges may be part of both the device's pre-implantation shape and thedevice's post-implantation shape.

In one embodiment, the cable member may conform to the ridges, providingincreased contact surface area between the device and the cable member.In another embodiment, the device may conform to the cable member or thebone recess. In yet another embodiment, the device and the cable member(and/or the bone recess) may conform, to some extent, to each other.

The device 200 may also have surface features (not shown), such astextures or porosity. For example, surface features may be provided forphysical purposes, such as increasing the fixing forces provided by thedevice. In one embodiment, the surface features are on the shape memorymaterial. In another embodiment, the surface features are on a part ofthe device that is not a shape memory material. In one embodiment, thesurface features may increase friction between a cable member and thedevice. In another embodiment, the surface features may increasefriction between a part of the bone recess and the device.

Surface features may also be provided for physiological purposes. Forexample, surface features may be provided to encourage bone in-growth.In one embodiment, surface features are configured in a manner thatencourages bone deposits and the surface features may hold bone-growthstimulants. In another embodiment, surface features are configured in amanner that encourages bio-compatability. In yet another embodiment,surface features are configured in a manner that encourages soft tissuegrowth.

The device 200 may have a curved or otherwise shaped tip to easeinsertion into the bone recess with a cable member. In one embodiment,the device has a curved tip in the device's pre-implantation shape. Inanother embodiment, the device has a curved tip in the device'spre-implantation shape and a differently curved tip in the device'spost-implantation shape.

In one embodiment, the device 200 has a cavity 206. In one embodiment,the cavity 206 is configured to accept a heating element (not shown) toaid in the application of heat to a shape memory material contained inthe device. For example, the cavity 206 may be spaced from the outersurfaces of the device 200 that contact cells that surround the device(e.g., living cells, human cells) that may be damaged by heating.Spacing of the cavity from outer surfaces of the device may allowactivation of a shape memory material in manners that limit the amountof heat transferred to surrounding cells. Inner walls of the cavity 206may be contacted using a heating element (not shown) to supply heat tothe inner walls of the cavity. Certain methods may be used to reduce theheat transferred to surrounding cells. For example, a method of usingheating “bursts” may be employed to limit heat transfer to surroundingcells.

In another embodiment, the cavity 206 is configured to accept a drug, abone cement, suture material, or another material. For example, amaterial may be inserted into the device 200 after the device has beeninserted into the bone recess 204. Delivery of material inserted intothe device may be achieved through absorption by the device, or throughchannels as described further below. In yet another embodiment, thecavity 206 is configured to accept a heating element and is configuredto accept material after the shape memory material has been activated.For example, a shape memory material may not have significant channelsbefore being activated (e.g., in the material's pre-implantation shape),and the shape memory material may have channels after being activated(e.g., in the material's post-implantation shape).

In another embodiment, the cavity 206 is configured to hold a guide wireto aid insertion of the device 200. For example, the guide wire may beused as is shown in FIG. 1. In one embodiment, the cavity 206 has oneopening on each of two ends of the device 200 while the device is in itspre-implantation shape, allowing a guide wire to be threaded through thedevice. In another embodiment, the cavity 206 has one opening on each oftwo ends of the device 200 while the device is in its pre-implantationshape, and the cavity 206 has only one opening on one end of the devicewhile the device is in its post-implantation shape. In yet anotherembodiment, the cavity 206 has another opening that does not changeshape during the device's change from the device's pre-implantationshape to the device's post-implantation shape.

The device 200 may come in a kit that also includes a packaging (notshown) that is removed before being inserted. The packaging may maintaina sterile environment around the device 200. For example, the packagingmay surround the device. In one embodiment, the packaging is aform-fitting packaging such as a shrink-wrap packaging. For example, thepackaging may provide a force resisting deployment of the device fromits pre-implantation shape to its post-implantation shape (e.g., throughshape memory effect, through an elastomeric response) before anappropriate time (e.g., installation). In another embodiment, thepackaging encloses the device 200 with another material. For example,the packaging may enclose the device in a sterile fluid or gas (e.g. apressurized compressible gas).

FIG. 3 shows a cross-section of another embodiment of a device 300installed and in a post-implantation shape with a cable member 302 in abone recess 304 in a bone 314. The device 300 fixes the cable member 302to the device 300 inside a cavity 306 within the device. The cavity 306within the device 300 is at least partially defined by a fixationelement 310.

The device 300 may incorporate any of the properties or elements ofother devices described herein.

The device 300 is configured to interface with a bone recess 304 and fixthe cable member 302 to the bone thereby. In one embodiment, the device300 is configured to fix a cable member to the device before interfacing(e.g., through insertion) with the bone recess. In another embodiment,the device is configured to interface with a bone recess and be fixed tothe bone recess before accepting and fixing a cable member in the cavity306. In yet another embodiment, the device is configured so that eitherthe cable member may be fixed to the device first or the device may befixed to the bone recess first.

The fixation element 310 may be constructed in many manners. In oneembodiment, the fixation element comprises by a solid body. In anotherembodiment, the fixation element comprises a liquid that is transformed(e.g., polymerized, cured) into a solid body to hold a cable memberafter the cable member is inserted. In this case, the device 300 mayalso be the mold in which the liquid is transformed.

Such a transformable liquid may be provided in a kit with the device 300in separate containers that must be mixed to create the transformableliquid. The kit allows a surgeon to create the device at the time ofsurgery in order to form the device into the shape necessary to fix thecable member in the bone recess 304.

For example, one or more monomers and cross-linkers may be provided inseparate containers in a kit that when mixed may be polymerized or mayautomatically polymerize. In an embodiment, the polymer created may be ashape memory polymer. Such a kit may also include a cable memberconfigured to function as a soft tissue replacement in a human body andthe cable member may be further configured to be partially encapsulatedin the shape memory polymer. As discussed in greater detail herein, thecable may be made from one or more of an animal tissue, a syntheticfiber, a natural fiber, a polymer, a metallic wire, a bundle, or acomposite.

Such a kit may also include a polymerizing device to initiate thepolymerization reaction, such as for example, a radiation source, anultraviolet light source, a heating source, and a source of electricalcurrent. Alternatively, the polymerization may be automatic or caused bya heat generated by the ambient environment or the patient. Otherdevices may also be included in the kit to assist the surgeon, such as amixing element like a spatula, one or more metering devices for meteringprecise amounts of monomer and crosslinking solutions, mixing vessels orplates which may also server dual purposes such as a mold or a heatconductor or insulator, and a support configured to hold the cablemember.

In yet another embodiment, the fixation element comprises a body (e.g.,a spring member) that folds or collapses upon itself in response to aforce (not shown) to hold the cable member, thereby allowing the cablemember to be inserted but not removed.

The fixation element 310 may adapt to accommodate a cable member 302when it is inserted. For example, the fixation element 310 may bedeformed (e.g., strained) by the cable member 302 as the cable member isinserted into the cavity within the device and the stress between thecable member and the fixation element may help fix the cable member tothe device. The cable member may also be deformed (e.g., strained) bythe fixation element 310 as the cable member is inserted into the cavitywithin the device and the resulting stress between the cable member andthe fixation element may help fix the cable member to the device.

The fixation element 310 may comprise a shape memory material (e.g., aSMP). A shape memory material may be used in the fixation element toprovide a source of strain and/or stress after insertion of the cablemember. For example, a cable member may be inserted into the cavity anda stress/strain relationship between the cable member and the fixationelement may be established as described herein. The shape memorymaterial contained in the fixation device may then be activated toproduce a different stress/strain relationship between the cable memberand the fixation device. The activation of shape memory materials andthe stresses and strains produced as a result of activation arediscussed further herein.

Shape memory materials may be used in other parts of the device as well.For example, shape memory materials may be used to aid in fixing thedevice to the bone recess as described in greater detail herein.

FIG. 4 shows a cross-section of another embodiment of a device 400installed with a cable member 402 in a bone recess 404 in a bone 414.The device 400 includes an external cavity 406, a channel 410, and aninternal recess 412. The external cavity 406 is connected to the channel410. The external cavity is connected to the internal recess 412. Thedevice may have more than one external cavity 406. The discussion of theexternal cavity 406 below may be applied to all shapes and shapefeatures of a device, such as the ridges discussed above with respect toFIG. 2 (those ridges may also form at least one external cavity on adevice).

The device 400 may incorporate any of the properties or elements ofother devices described herein.

An external cavity 406 may be used to interact with the cable member 402in a manner that aids the fixation of the device to the cable memberand/or the fixation of the cable member to the bone recess. In oneembodiment, the cavity 406 may buckle the cable member. In anotherembodiment, the cavity 406 may provide the cable member with an area ofdecreased stress, and potentially, decreased strain. The stress/straininteraction of a device, a cable member and a bone recess is describedfurther herein.

An external cavity may hold a material (e.g., a monomer solution, a bonecement, a drug) that is useful to have held against a cable member, abone recess or both. For example, a device 400 may allow for insertion(e.g., injection) of the material into the external cavity after thedevice has been installed with a cable member. In one embodiment, thedevice 400 allows for polymerization of a monomer liquid after thedevice has been installed with a cable member. In another embodiment, adevice allows for insertion of a drug (e.g., a bone-growth stimulant)into the external cavity 406 after installation (e.g., for dispensingthe drug over time to the bone recess and tendon).

In another embodiment, the cable member 402 may be attached to thedevice 400 or integrated with the device. In one embodiment, the cablemember 402 may be held by a shape memory polymer of the device 400 whilethe device is in the post-implantation shape. For example, a cablemember may contact a part of the device 400 (e.g., internal to thedevice, on an external wall) and the device may fixedly grip the cablemember 402 while the device is in the post-implantation shape. Inanother embodiment, the cable member 402 may be attached via apolymerization of a solution that is in contact with the device. Forexample, a solution containing a linear chain and a crosslinker may bepolymerized while contacting both the cable member and the device. Inone embodiment, the solution contacts an external surface of the device400. In another embodiment, the solution contacts an internal surface ofthe device 400. The cable member 402 also may be attached to the device400 as described further herein.

A channel 410 may connect with an external cavity 406. For example, achannel 410 and an external recess 406 may define a contiguous volume.In one embodiment, the channel 410 is substantially cylindrical inshape, defining a shape such as a tube or pipe. In another embodiment,the channel 410 is an irregular shape. The channel 410 may connect withan internal recess 412.

The channel 410 may provide a passage for transferring a material (e.g.,matter such as solids, liquids, gases) from an internal recess 412 andan external cavity 406. The channel 410 may store the material. Theinternal recess 412 may contain a drug or a bone cement agent. Theinternal recess 412 may also contain a polymerizing agent or anactivation agent. The channel 410 may also contain any of these drugs oragents.

Those with skill in the art will recognize that there need not be adefinite demarcation between an internal recess 406, a channel 410, andan external cavity 412, nor do those elements need to be identifiablydistinct. For example, an internal recess 412 may be connected with anexternal cavity 406 by an orifice that defines a boundary of both theinternal recess and the external cavity. In another embodiment, anorifice defines a boundary of the channel 410 and the external cavity.

An orifice may have a seal or flap restricting the transfer of matter(e.g., solids, liquids, gases) between the internal recess and theexternal cavity. For example, the seal (e.g., flap, orifice) may blocktransfers from the internal recess to the external cavity.

The seal or flap may comprise a shape memory material. In oneembodiment, the seal blocks transfers of matter before the shape memorymaterial is activated and the seal allows transfers of matter after theshape memory material is activated. In another embodiment, the sealallows transfers of matter differently before the shape memory materialis activated than after the shape memory material is activated.

Activation of a shape memory material in the device may cause theinternal recess to change. For example, the internal recess may bedefined by a shape memory material, the activation of which changes theinternal recess. In one embodiment, the activation of a shape memorymaterial lessens the volume of an internal recess (e.g., constricts therecess). For example, the constriction of the internal recess (e.g.,lessening of the volume of the recess) may deliver a drug contained inthe recess to the external cavity. In another embodiment, the activationof a shape memory material expands an internal recess (e.g., increasesthe volume of an internal recess). For example, the expansion of theinternal recess may create a low-pressure region (e.g., a partialvacuum) within the external cavity and the low-pressure region may aidin fixing the device to the cable member and/or the bone recess (e.g.,through a partial vacuum in an external cavity).

In an embodiment, a selection of multiple bone implant devices havingdifferent shapes and sizes may be packaged and sold as a kit. Theselection may include implants of different diameters, shapes orimplants exhibiting different properties. The components within the kitmay be pre-sterilized so that the kit may be opened and used duringsurgery without an additional sterilization step. The kit may includeone or more insertion devices for inserting the implants into the bonyrecess as described above. Such an insertion device may include a simplemetal tube shaped to engage with the one or more of the implants.Alternatively, the insertion device may be a sold shaft, a guide wire orsome other component adapted facilitate insertion by the surgeon. Forexample, an insertion device may include a threaded rod that engages ininterior threads provided by a threaded bore within the implant, whichmay be provided by a separate element such as a nut contained within theimplant. After insertion, the rod may be unscrewed from the implant anddiscarded. Such an insertion device may also be used in the activationof the activation implant. For example, a stainless steel insertion rodmay be heated in order to heat the implant. The kit may further includeinstructions for selecting the appropriate implant.

FIG. 5 shows flow-chart of a method 500 for performing surgery. Themethod 500 may be embodied as a surgical procedure for repairing ajoint, ligament, tendon or other anatomical part. The method 500includes inserting a cable member 510 into a bone recess, inserting aretention device 512 into the bone recess, activating a shape memorymaterial 514.

The method 500 may include fixing the cable member to the bone recess(not shown). In one embodiment, the method 500 performs the fixing thecable member to the bone recess operation via fixing the cable member tothe retention device. In another embodiment, the method 500 performs thefixing the cable member to the bone recess operation via pinning thecable member between the retention device and a wall of the bone recess.

The method 500 includes creating a bone recess 502. Creating a bonerecess 502 may be performed using techniques now known in the art (e.g.,drilling), or using techniques that are yet to become known. In oneembodiment, the creating a bone recess operation 502 may be adapted tocreate a larger surface area of bone with which a retention device maycontact the bone. In another embodiment, the creating a bone recessoperation 502 may be adapted to provide access to a bone site used forconnecting a cable member (e.g., through the use of a retention device).

The method 500 includes dilating the recess in the bone 504. In oneembodiment, the dilating the recess in the bone operation 504 is atleast partially performed via compacting bone tissue surrounding therecess in the bone (e.g. 506). In another embodiment, the dilating therecess in the bone operation 504 is performed by shaving bone tissuefrom the walls of the bone recess.

The method 500 includes compacting bone tissue surrounding the recess inthe bone 506. The compacting bone tissue operation 506 may be performedby many techniques. For example, a shape memory material in a retentiondevice may produce sufficient pressure to compact the bone tissuesurrounding a bone recess.

In one embodiment, the inserting a cable member operation 510 isperformed before the inserting a retention device operation 512. Forexample, the cable member may be inserted 510 against a wall of the bonerecess and the retention device may be inserted against the cable memberand another wall (or another part of the same wall) of the bone recess.In another embodiment, the inserting of a retention device operation 512is performed before the inserting a cable member operation 510. Forexample, the retention device may be inserted 512 against a wall of thebone recess (e.g., it may contact two walls, opposite sides of the samecylindrical wall, or may fill the bone recess, contacting substantiallyall the walls of the recess), and the cable member may be inserted 510into the retention device. It should be noted that when the cable memberis inserted 510 into the retention device, it is necessarily beinginserted into the bone recess, if the retention device itself is in thebone recess.

In yet another embodiment, the inserting a cable member operation 510and the inserting a retention device operation 512 are performedsimultaneously. For example, a part of a cable member may be connectedor coupled with a retention device and the combined cable member andretention device structure may be inserted into the bone recess. In oneembodiment, the cable member may only be partially inserted into a bonerecess. In another embodiment, the retention device may be fullyinserted into a bone recess.

The method 500 may also include initiating a polymerization of a monomersolution (not shown). In one embodiment, a monomer solution is insertedinto a cavity within the retention device, a cable member is insertedinto the cavity, and a polymerization of the monomer solution isinitiated (e.g., through heating the solution or irradiating thesolution). In another embodiment, such a cavity configured for holding amonomer solution exists in the post-implantation shape of the retentiondevice.

After the inserting a cable member operation 510 and the inserting aretention device operation 512 have been performed, the cable member andthe retention device may be positioned within the bone recess in anumber of configurations. Any of the configurations described herein maydefine the relative positions of a cable member and a retention device.For example, any of the devices in the herein description may be used asa retention device. In one embodiment, a cable member may be fixedwithin a cavity of the retention device. In another embodiment, a cablemember may be fixed between a wall of the bone recess and an outersurface of the retention device.

In one embodiment, the inserting a retention device operation 512 may beperformed by inserting one of the devices described herein comprising ashape memory material. In another embodiment, the inserting a retentiondevice operation 512 may be performed by inserting a device separatefrom a shape memory material and the activating a shape memory materialoperation 510 may be performed on a shape memory material memberseparate from the device that is inserted into the bone recess.

The method 500 includes activating a shape memory material 514. Theactivating a shape memory material operation 510 may be performed in themanners further described herein. In one embodiment, the activating ashape memory material operation 514 may be performed by providing heatto the shape memory material. In another embodiment, the activating ashape memory material operation 514 may be performed by irradiating theshape memory material with electromagnetic radiation. The activating ashape memory material operation 514 may also be performed in manners yetto become known.

The method 500 may also include attaching sutures to the retentiondevice and/or the cable member. In one embodiment, a suture may beattached to a part of the retention device and threaded through a partof the cable member. In another embodiment, a suture may be attachedfrom one part of a cable member to another part of the cable member.

FIG. 6 shows a flow-chart of a method 600 of manufacturing devices. Themethod 600 includes shaping a polymer material 602 into apost-implantation shape, deforming the polymer material 604 into apre-implantation shape, and cooling the polymer material 606 to below acertain temperature.

The method 600 includes cooling the polymer material 606 to below acertain temperature. The certain temperature may be the glass transitiontemperature of the polymer material. In one embodiment, the cooling thepolymer material operation 606 is performed after the deforming thepolymer material operation 604. For example, the polymer material may beabove the glass transition temperature while the deforming the polymermaterial operation 604 is performed. In another embodiment, the coolingthe polymer material operation 606 is performed before the deforming thepolymer material operation 604.

The shaping the polymer material operation 602 may be performed in manymanners. In one embodiment, the polymer material may be polymerized froma solution into a solid body while in a mold. For example, the mold maydefine a post-implantation shape or a pre-implantation shape. In anotherembodiment, the polymer material may be shaped via cutting; milling,turning (e.g., using a lathe), or other techniques used for shapingmaterials. As another example, the mold may hold a solution and a cablemember while the solution is polymerized around an end of the cablemember.

The shaping the polymer material operation 602 and the deforming thepolymer material operation 604 may result in pre-implantation shapes andpost-implantation shapes such as those described herein.

In another embodiment, the process 600 may include polymerizing asolution (not shown) around a cable member (e.g., while an end of acable member is inserted in the solution). The polymerizing a solutionoperation may be performed to provide a strong interface between a cablemember and a polymer solution. The polymerizing a solution operation mayalso be performed to create a device that has a cable memberincorporated in the device (e.g., attached to the device, part of thedevice). For example, a device with an incorporated cable member may beused to facilitate surgery or to verify attachment between the deviceand cable member before a surgical procedure is begun. The incorporationof a cable member in a device is further described herein in relation toother devices and methods.

Polyethylene glycol dimethacrylate-poly methyl methacrylate(PEGDMA-PMMA) compositions and polyethylene glycol-poly methylmethacrylate (PEG-PMMA) are described herein as examples of SMPs thatmay be used for devices. PEGDMA-PMMA and PEG-PMMA are described hereinpartially because of the biocompatability of the substances and the highforces the substances are often able to generate. PEGDMA may be referredto as PEG for short, although PEG may mean other functionalized forms ofpolyethylene glycol.

By combining PEG with a functional group (e.g, DMA) into novel SMPcompositions, a range of glass transition temperatures and installmentforces (e.g., post-implantation forces creating pressures on bonerecesses) may be selected. In some instances, the glass transitiontemperature of a SMP composition will vary with (or otherwise be relatedto) the installment force achievable by the SMP. By utilizing two ormore different cross-linkers, the relationship between the glasstransition temperature of a SMP and the installment force achievable bythe SMP may be varied or even non-associated (e.g., the Tg andinstallment force may be varied independently).

The percentage (as a function of total weight of the polymer, or byweight) of cross-linker in the polymer composition may also be varied.The amount of cross-linker in a polymer composition may be varied tochange the polymer compositions characteristics (e.g., strength, force,glass-transition temperature, response time, elasticity). In oneembodiment, a cross-linker may comprise about 5% or less of a polymercomposition. In another embodiment, a cross-linker may comprise morethan about 10% of a polymer composition. In yet another embodiment, across-linker may comprise about 80% of a polymer composition.

The following examples describe some of the experimental resultsachieved with respect to creating SMPs with various glass transitiontemperatures and installment forces.

EXAMPLES

Experimental work on SMP systems used in graft fixation devices wasperformed to demonstrate the feasibility and advantages of these devicesover currently used ACL fixation devices.

The following examples are presented to demonstrate a SMP polymerizationprocess, fabrication, characterization and testing of materials inaccordance with the present invention. These examples are not intendedto limit the scope of the invention in any way. All starting materialsare commercially available. Thermomechanical characterization wasperformed by dynamic mechanical analysis (DMA) on a Perkin Elmer DynamicMechanical Analyzer DMA-7.

Example 1 SMP Fabrication

Tert-butyl acrylate (tBA) monomer (Aldrich), poly (ethyleneglycol)dimethacrylate (PEGDMA) cross-linker (Aldrich), and the photoinitiator2,2-dimethoxy-2-phenylacetophen one (Aldrich) were used in theiras-received condition without further purification. A polymer solutionwas formulated by combining 10 wt % PEGDMA, 0.1 wt % initiator, with thebalance tBA. Other crosslinker/momomer ratios can be considered and canrange from 1 wt %-99 wt % cross-linker. Other photoinitiators includeacetophenone, anisoin, anthraquinone, benzene chromium tricarbonyl,benzil, benzoin, benzoin ethyl ether, berizoin isobutyl ether, benzoinmethyl ether, benzophenone, 4-benzoylbiphenyl,2-benzyl-2-(dimethylamino)-4′-morpholinobutyrophenone,4,4′-bis(diethylamino)-4′ benzophenone,4,4′-bis(dimethylamino)-4′benzophenone, camphorquinone,2-chlorothioxanthen-9-one, dibenzosuberenone, 2,2-diethoxyacetophenone,4,4′-dihydroxybenzophenone, 4-(dimethylamino)benzophenone,4,4′-dimethylbenzil, 2,4(5)′-dimethylbenzophenone,3,4-dimethylbenzophenone, 4′-ethoxyacetophenone, 2-ethylanthraquinone,ferrocene, 3(4)′-hydroxyacetophenone, 3(4)′-hydroxybenzophenone,1-hydroxycyclohexyl phenyl ketone, 2-hydroxy-2-methylpropiophenone,2(3)-methylbenzophenone, methyl benzoylformate,2-methyl-4′-(methylthio)-2-morpholinopropiophenone, phenanthrenequinone,4′phenoxyacetophenone, thioxanthen-9-one, triarylsulfoniumhexafluoroantimonate salts, and triarylsulfonium hexafluorophosphatesalts.

Glass slides, approximately 1″×3″×1 mm, were precoated with ahydrophobic polymer glass treatment solution RainX glass treatment soldby SOPUS Products, Houston, Tex.), which acted as a non-reactivereleasing agent. The glass slides were separated with 1 mm spacers. Theabove solution was mixed manually in a glass vial and then injectedbetween two glass slides using a pipette. Photo-polymerization was thenachieved by placing the solutions under a UV lamp (Model B100AP, UVPBlak-Ray) at an intensity of ˜10 mW/cm² for 10 minutes. Samples forthermomechanical testing were laser cut from the polymer to dimensionsof 20 mm×5 mm×1 mm. The edges of the samples were polished using600-grit silicon carbide sandpaper to remove any edge effects caused bythe laser cutting. The material was stored in a refrigerator with nolight contact.

SMP's may be photopolymerized in a semi-LV transparent mold. Thisincludes polymerization through glass molds, such as test tubes orcustom shaped glassware, silicone molds, or any degradable mold, such aswater-soluble molds. Thermal initiation can be used in place ofphoyopolymerization. With thermal initiation, the initiator reacts toheat instead of UV light. Benzoyl-peroxide and other thermal initiatorscan be used. In this case, any removable mold may be used in molding SMPdevices. Other methods of machining include CNC machining for complexgeometries and lathing for cylindrical specimens.

Storage and stability of the polymer were tested in two ways. First, apackaged plug was stored in a freezer for ˜1 year under no constraint.The plug was then heated in a body temperature bath and the plugrecovered to its original shape (e.g., unconstrained shape, pre-deformedshape). Second, samples were placed in a body temperature saline bath(pH=7.4) for 6 months. Weight measurements (to determine if anyhydrolytic degradation had occurred) were taken every 2-4 weeks. Thepolymer showed no signs of weight loss or degradation after 6 months.

Example 2 SMP Thermomechanical Characterization

The polymer samples were tested using a Perkin Elmer Dynamic MechanicalAnalyzer (DMA-7). A three-point flexural configuration was used forglass transition (T_(g)), strain recovery, and stress recovery tests(FIG. 24 inset). The three-point flexure loading allowed reasonablestress/strain levels in the sample for the temperature range spanningthe glassy to the rubbery state. In particular, this configurationallowed 30% maximum bending strain over a 5 mm span during the stressand strain recovery tests. FIG. 24 shows a comparison between the PEGDMAcopolymer and PLA, which is a biodegradable polymer used in tibialdevices. The drop in storage modulus as temperature increases indicatesthe material is transforming from a glassy or stiff state to a rubberystate. Also, T_(g) may be defined in relation to the peak of the tandelta curve.

The glassy storage modulus is an indication of the material's stiffness.A SMP plug will have a stiffness close to PLA after installation.Furthermore, PLA will show some minor shape memory effect around itsglass transition. It may then be possible to engineer the PLA system toexhibit a large shape memory effect. The material selected for thisstudy is not the only choice. It may be possible, with the correctpolymer engineering, to match the necessary material characteristic tocurrent FDA approved polymer devices.

The test results shown in FIG. 24 may offer insight into thethermomechanics of shape-storage deformation and shape recovery of SMPs.A three-point flexural configuration (shown in FIG. 24) may be used forglass transition, free strain recovery, and stress recovery tests. Inall tests, heating and cooling is typically performed at a constant rateof 5° C./min with data collection every 2 seconds. For example, in Tgtests, samples were cycled at a frequency of 1 Hz between minimum andmaximum bending forces of 10 mN and 90 mN. The glass transitiontemperature (Tg) of the polymers was tested over a range of 100° C. anddepended on the molecular weight and concentration of the crosslinker.The polymers showed a 100% strain recovery up to maximum strains ofapproximately 80% at low and high deformation temperatures (Td). Freestrain recovery depended on the temperature during deformation. Forexample, lower deformation temperatures (Td<Tg) decreased thetemperature required for free strain recovery. Constrained stressrecovery shows a complex evolution as a function of temperature and alsodepends on Td. In an embodiment, using variations of crosslinkingdensity, nano reinforcement, fiber reinforcement, the amount ofdeformation (e.g., the ratio of compression, the ratio of expansion), orlayering, a SMP may withstand a range from 0.5 MPa to 20 MPa stresslevels. Tendon slippage is unlikely to occur with installed fixationloads above about 0.25 MPa.

Example 3 Plug Manufacturing

The test plug material was machined from a 45 wt % PEGDMA ratio to 55%PMMA (poly methyl methacrylate) with a 0.1% photo initiator and mixed ina 14 mm diameter glass test tube. The open end of the test tube wasblocked off with a rubber stopper and the test tube plus solution wasplaced in a 0° C. water bath under a UV lamp for 10 minutes. The glasstest tube was then removed leaving a 14 mm PEGPMMA cylinder with a glasstransition temperature (T_(g)) of 40° C. The plugs were machined fromthe cylinder stock using coconut oil as lubricant and spinal speeds of450 RPM to be approximately 11.5 mm in diameter and 25.4 mm in length.The edges of the device were filleted to 0.5 mm radii to ensure thedevice would not shear a soft tissue (tendon) on contact.

In addition, various unconstrained (or un-deformed) shapes were createdto demonstrate multiple forms of possible unconstrained shapes, shown inFIG. 7. Unconstrained shapes and their differences frompost-implantation shapes are described further herein.

The plugs were then coated with lubricant (e.g., spray Teflon) andprepared for insertion in an extrusion apparatus. The extrusionapparatus deforms plugs into a deformed shape, for example, into apre-implantation shape. FIG. 8 shows the three extrusion stages that theSMP undergoes in the current setup. The extrusion unit 800 operates byplacing the un-deformed plug in an entry zone 802 in the extrusion unit800 and applying a pressure using a hardened pressure bar 810 to pushthe plug into the reduction zone 804. An additional plug (or dummy plug)may be inserted to transmit a force onto the plug in the reduction zone804 and further deform the plug to conform with the final zone 806(e.g., the plug being then in a pre-implantation shape). After thepolymer has been fully extruded into the final dimension zone, theextrusion unit is placed in a controlled temperature environment belowthe polymers glass transition, to allow the polymer to set in itstemporarily deformed stored shape. The polymer may then be released atroom temperature or below (depending on the Tg of the polymer). FIGS. 9a and 9 b, show the pre-deformed shape (the original shape orunconstrained shape) and the deformed shape (pre-implantation shape).Storing the deformed plug at a temperature below its glass transitiontemperature can reduce incidence of premature deployment (e.g.,expansion to post-implantation shape or unconstrained shape depending onconstraints present during deployment).

The geometry and material mechanics were varied during experimentation.FIG. 10 shows different tip geometries of devices used during theinstallation process to analyze the effect of device insertion force asa function of geometry. The experimental results indicated devices withthe more tapered or “aerodynamic” appearing configurations provided theeasiest insertion into bone recesses.

Several different polymers compositions were used to vary the recoveryforce of the SMP, for example the 20 wt % PEG to tBa system shows alower recovery force than the 40, 45, 50 wt % PEG to PMMA compositions,FIG. 11. This allows for the recovery force of the polymer to be variedwith regards to linear chain material and percent crosslinking. Thevariation in percent crosslinker also affected the glass transition andallowed the polymer to recover at different temperatures. FIG. 12 showsthe free strain recovery time after devices (e.g., SMP plugs) werestrained (e.g., deformed) between about 25% and about 30% then stored inthe strained state before recovery was initiated. The T_(recovery)(e.g., recovery temperature) indicated in the figure references thetransition temperature of the device. FIG. 13 shows constrained recoverytime as a function of crosslinking.

After performing the above experiments, plugs were created to have a 45wt % PEG PMMA composition with the crosslinker having a molecular weightof 875. This allowed for the optimal deployment temperature to be bodytemperature. The deployment temperature can be raised or lowered bychanging the material composition. Changing material composition willalso influence the deployment time and force after activation.

Example 4 Recovery Force

Two forms of testing have been designed to compare the utility of thecurrent interference screw to utility of a SMP fixation device (e.g., aSMP plug). The first test analyzed the force caused from the recovery ofa 20 wt % PEG tBa SMP plug when confined in a 10 mm tunnel with tendon.To simulate the boney tunnel, the custom fixture (FIG. 14) wasmanufactured from aluminum and mounted inside a thermally controlledchamber. The plug (2) in its deformed position was placed betweenaluminum constraints (1) and the extension fixed. The temperature wasincreased gradually over time and the SMP plug recovered graduallyresulting in a compressive loading being applied to the aluminum fixture(FIG. 14). It should be noted that the SMP plug recovered viacontracting some of the plug's dimensions and expanding some of theplug's dimensions. The results, FIG. 15, show the recovery load of an 11mm diameter SMP plug is approximately 600N. This force is arbitrary andcan be increased or decreased by, for example, changing the dimensionsof the SMP plug (e.g., in the unconstrained shape or original shape) orchanging the composition of the SMP (e.g., changing the type orpercentage of cross-linker). This is because the recovery force isdependant on the geometry and composition of the plug, which can bechanged during the manufacturing process.

The second test, FIG. 16, measured the forces for the prior artinterference screw during insertion and after insertion. This wasachieved by recording the force exerted on a 10 mm constrained tunnel(e.g., through the fixture in FIG. 14) during insertion of a 10 mminterference screw. FIG. 16 shows the immediate increase and relaxationin the force levels (e.g., loads) during the installation of theinterference screw and a gradual relaxation of the device and tendonconstruct post-installation. The spiking and relaxation of the loads inthe interference screw are directly related to an application of avariable torque to the device used to install the screws.

Example 5 Failure Strength

FIG. 17 shows the test setup for the in-vitro maximum failure strengthand cyclic strength of the ACL tendon construct. Three hundred bovineknees were harvested and cleaned of soft tissue. 100 bovine extensortendons were also harvested. The bone mineral density of the specimensranged from 0.78 g/cm³ to 0.84 g/cm³, thus closely approximating thebone mineral density of young human tibia.

The bone was mounted into a custom made fixture (FIG. 17), whichprovided access to the distal opening of the tibial tunnel. A 10-mmdiameter tibial tunnel was drilled from the anteromedial proximalmetaphysis to the mid-articular surface of the proximal tibia with theaid of a standard ACL tibial guide set to fifty-five degrees. Afour-stranded, non-weaved cable member (e.g., graft) was prepared bypassing tendons (10 mm sized) over doubled number 1 absorbable sutures.Each end of the four-stranded graft was secured with a running,interlocking, whip stitch using #1 fiberwire in order to apply tensionto each limb of the graft during fixation. Unfortunately, due to thein-vitro deployment simulation requirements of the SMP plug, thisinitial pretension force was lost. After the soft tissue graft waspassed retrograde through the 10 mm tibial tunnel, a 4 mm stainlesssteel rod was passed through the looped end of the graft and attached tothe upper cross head of a screw driven uniaxial testing machine,representing the femoral fixation site. The SMP plug was then insertedin its deformed position to the approximate center of the tendonconstruct as shown in FIG. 17. The entire specimen was removed andplaced in body temperature saline for 30 minutes to initiate shapememory recovery. The specimen was then placed back into the customfixture. Using extension control the crosshead was run at 0.25 mm/secuntil a displacement of 30 mm had been reached.

The shape memory polymer material selected for these plugs was 45 wt %PEGDMA to PMMA and manufactured to have an initial deployed diameter of11.5 mm and a length of 25.4 mm. The plugs were then deformed using aextrusion unit (e.g., extrusion device described in example 3) to afinal diameter of 8 mm. The deformed plugs were stored at 0° C. in aglass vial until 5 min prior to installation. The glass plugs were theninserted using a 10 mm diameter, 3 inch long cylindrical shaped push rodused to insert the plug into position.

FIG. 18 shows experimental results comparing SMP fixation devices(ShapeLoc devices by MedShape Solutions, Inc., Castle Rock, Colo.) and aDelta Interference Screw (by Arthrex, Inc., Naples, Fla.). FIG. 19 showsexperimental results comparing tensile strengths and displacement ratiosof the cyclic response (e.g., response to multiple cycles) of a ShapeLocfixation device. FIG. 20 a shows mean and standard deviations of tensilestrengths of various fixation devices. FIG. 20 b shows mean and standarddeviations of sniffinesses of various fixation options. FIG. 20 c showsmean and standard deviations of slip rates of various fixation options.

Example 6 Tissue Incorporation

A photo-polymerization process allows for a cable member (e.g., asynthetic graft, a living tissue) to be encapsulated within a polymermaterial. In one embodiment, the encapsulation provides a more completeinterface, thus reducing the incidence of a cable member (e.g., atendon) slipping or tendon-device damage. In another embodiment, theencapsulation provides an interface that may be tested beforeinstallation in a surgery site.

The use of the PEGDMA-PMMA system allows for strong adhesion between thetendon and the device. This allows the graft to be directly attached(e.g., polymerized) to the fixation device.

The shape memory polymer system used for this example was the 45 wt %PEG to PMMA and prepared similar to example 1. FIG. 21, shows a tissueencapsulation setup and is described below. The tendon was sized to beinserted into a 10 mm tunnel. The tendon was carefully wrapped in a coldsaline soaked cloth leaving only a 25 mm portion of the tendons distalend exposed. A 12 mm glass test tube was then coated with a hydrophobicpolymer glass treatment solution (RainX glass treatment sold by SOPUSProducts, Houston, Tex.) and the SMP solution was poured into the baseof the tube. The tendon, leading with the uncovered end was lowered intothe polymer solution until the upper looped portion was restricted witha crosspin. The distal tendon ends were pressed against a wall of thetest tube. The setup, shown in FIG. 21, was then placed under the directcontact from a UV lamp and was slowly rotated over a course of 10minutes until full polymerization had occurred. The combined tendon andpolymer device was then removed from the glass tube and stored in ahousehold freezer.

This example represents the idea of incorporating the tendon directly tothe device prior to surgical installation. Example 7 will illustrate theuse of the device to provide a barrier to allow the tendon and SMP plugto be installed within the bone tunnel, followed by a monomer solutionbeing polymerized inside the tunnel.

Example 7 Tissue Incorporation

In this experiment a SMN device was machined (e.g., lathed) from 45 wt %PEG to PMMA to resemble a “dog bone” type shape. The two ends weredeformed at 60° C., as shown in FIG. 22 a, and stored at 0° C. Thedeformed SMP plug was inserted with a 10 mm sized tendon into a 10 mmfoam bone tunnel (used to model human bone). The foam, tendon anddeformed device (e.g., device in its pre-implantation shape) was thenplaced in body temperature saline and heated for 10 minutes. FIGS. 22a-c show the device during the device's change from a pre-implantationshape (FIG. 22 a) through a mid-deployment shape (FIG. 22 b), toward thedevice's unconstrained shape (FIG. 22 c). After the device showed nearfull change to the post-implantation shape (as installed) an 18 Gsyringe was used to deposit a mixture of 45 wt % PEG to PMMA solutionwith 0.1% photo-initiator. Next an ultraviolet light source was locatedat the open end of the tunnel and initiated the free radicalpolymerization through the SMP device of the solution (45 wt % PEG toPMMA solution with 0.1% photo-initiator) distributed around the device(FIG. 23).

There are two reasons for using a SMP device in this example. The firstreason is to ensure the maximum amount of the soft tissue comes into thecontact with the bone tunnel wall. This will aid the healing and tendonregeneration process. The second reason is to allow a barrier torestrict the use of the PEG-PMMA mixture to only the boney tunnel. Anadditional method is the use of a thermal initiator with an activationtemperature at body temperature. This would allow the initial SMP plugto hold the tendon in place while the remaining PEG-PMMA solution (oreven a homomonomer of PMMA) polymerizes over time due to the heat energygenerated from body temperature.

While various embodiments have been described for purposes of thisspecification, various changes and modifications may be made which willreadily suggest themselves to those skilled in the art and which areencompassed in the spirit of the invention both disclosed herein and asdefined in the appended claims.

Unless otherwise indicated, all numbers expressing quantities ofingredients, properties such as molecular weight, reaction conditions,and so forth used in the specification and claims are to be understoodas being modified in all instances by the term “about.” Accordingly,unless indicated to the contrary, the numerical parameters set forth inthe following specification and attached claims are approximations thatmay vary depending upon the desired properties sought to be obtained bythe present invention. At the very least, and not as an attempt to limitthe application of the doctrine of equivalents to the scope of theclaims, each numerical parameter should at least be construed in lightof the number of reported significant digits and by applying ordinaryrounding techniques.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope of the invention are approximations, the numericalvalues set forth in the specific examples are reported as precisely aspossible. Any numerical value, however, inherently contains certainerrors necessarily resulting from the standard deviation found in theirrespective testing measurements.

1. A device for use as a bone implant comprising: a body having apre-implantation shape and a post-implantation shape different from thepre-implantation shape; wherein the body is configured to change fromthe pre-implantation shape to the post-implantation shape in response tothe body being activated; and wherein the body is configured to beinserted in a bone recess while the body is in the pre-implantationshape.
 2. The device of claim 1, wherein the body further comprises ashape memory material.
 3. The device of claim 2, wherein the body isconfigured to change from the pre-implantation shape to thepost-implantation shape largely due to the shape memory effect of theshape memory material.
 4. The device of claim 1, wherein the body isconfigured to couple with the bone recess when the body is in thepost-implantation shape.
 5. The device of claim 1, wherein the bodycomprises a material that has no significant shape memory effects. 6.The device of claim 1, wherein the post-implantation shape is selectedfrom a substantially cylindrical shape, a dumbell type shape, acylindrical shape with ridges, and a threaded screw-like shape.
 7. Thedevice of claim 2, wherein the shape memory material is configured tofix a cable member to the body.
 8. The device of claim 7, wherein thecable member is selected from an animal tissue, a synthetic fiber, anatural fiber, a polymer, a metallic wire, a bundle, and a composite. 9.The device of claim 8, wherein the animal tissue is human soft tissue.10. The device of claim 2, wherein the shape memory material is selectedfrom a shape memory polymer, a shape memory metal alloy of nickel, ashape memory alloy of titanium, a shape memory foam, and a shape memoryceramic.
 11. The device of claim 1, wherein the body comprises a cavity.12. The device of claim 11, further comprising a drug within the cavity.13. The device of claim 11, further comprising a shape memory material,wherein the cavity is at least partially defined by a shape memorymaterial.
 14. The device of claim 11, wherein the body in thepre-implantation shape allows insertion of a cable member within thecavity.
 15. The device of claim 14, wherein the cavity is substantiallyconstricted while the body is in the post-implantation shape.
 16. Thedevice of claim 11, wherein the cavity is configured to accept anactivating element.
 17. The device of claim 14, wherein the cavity isspaced from an outer surface of the body to limit the amount of heatthat is transferred through the outer surface of the body when heat isapplied by an activating element.
 18. The device of claim 11, whereinthe cavity comprises an opening on an outer surface of the body.
 19. Thedevice of claim 18, wherein the cavity comprises a recess, the recessconnected with an outer surface of the body.
 20. The device of claim 19,further comprising a drug within the recess.
 21. The device of claim 1,further comprising a cable member.
 22. The device of claim 21, whereinthe cable member is attached to the body.
 23. The device of claim 21,wherein the cable member is selected from an animal tissue, a syntheticfiber, a natural fiber, a polymer, a metallic wire, a bundle, and acomposite.
 24. The device of claim 23, wherein the animal tissue ishuman soft tissue.
 25. The device of claim 1, wherein the body furthercomprises a cable member.
 26. The device of claim 25, wherein the cablemember is selected from an animal tissue, a synthetic fiber, a naturalfiber, a polymer, a metallic wire, a bundle, and a composite.
 27. Thedevice of claim 26, wherein the animal tissue is human soft tissue. 28.The device of claim 1, wherein the body is selected from a soft tissuegraft fixation device, a tendon fixation device, a joint capsule repairdevice, a tissue tack for labral, a tissue tack for bicep repair, asuture anchor, an orthopedic screw, a fixation screw for tenodesis, anda hard tissue spacer.
 29. The device of claim 1, further comprising apackaging member, the packaging member configured to surround the bodyand configured to maintain the body in a sterile environment.
 30. Thedevice of claim 29, wherein the packaging member is configured toconstrain the body to the pre-implantation shape.
 31. The device ofclaim 1, wherein the body is further configured to create a load withinthe bone recess and normal to a surface element of the bone recess inexcess of 10 KPa.
 32. The device of claim 31, wherein the load is lessthan 1 GPa.
 33. The device of claim 11, wherein the cavity comprises amold configured to hold a monomer solution.
 34. The device of claim 13,wherein the cavity comprises a mold while the shape memory material isin the pre-implantation shape.
 35. The device of claim 1, wherein thebody is configured to be activated via receiving heat.
 36. The device ofclaim 1, wherein the body is configured to be activated via absorbingelectromagnetic radiation.
 37. The device of claim 1, wherein the bodyis configured to be activated via the removing of constraints on thesurface of the body.
 38. The device of claim 1, wherein the body furthercomprises an elastomer.
 39. The device of claim 38, wherein the body isconfigured to be deformed into the pre-implantation shape by a force onthe body.
 40. The device of claim 39, wherein the force on the body isapplied by a tube.
 41. The device of claim 39, wherein the body isconfigured to change from the pre-implantation shape to thepost-implantation shape largely due to the removal of the force on thebody.
 42. The device of claim 1, wherein the change from thepre-implantation shape to the post-implantation shape comprises anexpansion.
 43. The device of claim 1, wherein the change from thepre-implantation shape to the post-implantation shape comprises acontraction.
 44. The device of claim 1, wherein the bone recess is a gapbetween a first surface of a first bone and a second surface of a secondbone.
 45. The device of claim 44, wherein the first surface and thesecond surface are components of a joint.
 46. A method comprising:inserting a cable member into a recess in a bone; inserting a retentiondevice into the recess, the retention device containing a shape memorymaterial; and activating the shape memory material.
 47. The method ofclaim 46, further comprising: fixing the cable member to the recess. 48.The method of claim 46, further comprising: creating the recess in thebone.
 49. The method of claim 46, further comprising: dilating therecess in the bone.
 50. The method of claim 46, further comprising:compacting bone tissue surrounding the recess in the bone.
 51. Themethod of claim 46, wherein the cable member is selected from an animaltissue, a synthetic fiber, a natural fiber, a polymer, a metallic wire,a bundle, and a composite.
 52. The method of claim 51, wherein theanimal tissue is human soft tissue.
 53. The method of claim 46, furthercomprising: initiating a polymerization of a monomer solution.
 54. Themethod of claim 46, wherein activating comprises performing an operationon the shape memory material, selected from heating, exposing to radiofrequency electromagnetic radiation, exposing to infraredelectromagnetic radiation, exposing to ultraviolet electromagneticradiation, and subjecting to a voltage differential.
 55. The method ofclaim 46, wherein the inserting the cable member operation precedes theinserting the retention device operation.
 56. The method of claim 46,wherein the inserting the cable member operation is performedsimultaneously with the inserting the retention device operation. 57.The method of claim 46, wherein after the activating operation isperformed, the retention devices contacts the recess in the bone andcontacts the cable member.
 58. The method of claim 46, wherein after theactivating operation is performed, the cable member is held by theretention device and the cable member does not substantially contact therecess in the bone.
 59. A kit comprising: a first bone implant, thefirst bone implant having a first pre-implantation shape and a firstpost-implantation shape different from the first pre-implantation shape;wherein the first bone implant is configured to be inserted in a firstbone recess while the first bone implant is in the firstpre-implantation shape; wherein the first bone implant is configured tofix a cable member to the first bone recess while the first bone implantis in the first post-implantation shape; and a second bone implant, thesecond bone implant having a second pre-implantation shape and a secondpost-implantation shape different from the second pre-implantationshape; wherein the second bone implant is configured to be inserted in asecond bone recess while the second bone implant is in the secondpre-implantation shape; wherein the second bone implant is configured tofix the cable member to the second bone recess while the second boneimplant is in the second post-implantation shape; wherein the secondpost-implantation shape is different from the first post-implantationshape.
 60. The kit of claim 59, further including an insertion deviceconfigured to aid the insertion of the first bone implant.
 61. The kitof claim 60, wherein the insertion device comprises a tube.
 62. The kitof claim 60, wherein the insertion device comprises a shaft.
 63. The kitof claim 60, wherein the insertion device comprises a guide wire. 64.The kit of claim 60, wherein the insertion device is configured toseparate into a first member and a second member.
 65. The kit of claim64, wherein the first member is configured to be fixed in the first bonerecess.
 66. A method comprising: shaping a polymer material into apost-implantation shape; deforming the polymer material into apre-implantation shape different from the post-implantation shape, whilemaintaining the temperature of the polymer material above a certaintemperature; and cooling the polymer material to below the certaintemperature while holding the polymer material in the pre-implantationshape.
 67. The method of claim 66, wherein the pre-implantation shape isa plug.
 68. The method of claim 66, wherein the pre-implantation shapecomprises a cavity.
 69. The method of claim 66, wherein thepre-implantation shape comprises a channel and a recess.
 70. The methodof claim 69, further comprising: filling the recess with a drug.
 71. Themethod of claim 66, wherein the certain temperature is a transitiontemperature of the polymer material.
 72. The method of claim 66, furthercomprising: polymerizing a material around a cable member.
 73. A kitcomprising: a first solution comprising a monomer, the first solutioncontained in a first container; a second solution comprising across-linker, the second solution contained in a second container;wherein the second solution is configured to form a third solution ifthe second solution is mixed with the first solution; wherein the thirdsolution is capable of forming a shape memory polymer uponpolymerization; and a cable member configured to function as a softtissue replacement in a human body.
 74. The kit of claim 73, furthercomprising a polymerizing device, the polymerizing device configured topolymerize the third solution into a shape memory polymer.
 75. The kitof claim 74, wherein the polymerizing device is selected from aradiation source, an ultraviolet light source, a heating source, and asource of electrical current.
 76. The kit of claim 73, wherein the thirdsolution is configured to be polymerized via receiving heat from a humanbody.
 77. The kit of claim 73, wherein the cable member is furtherconfigured to be partially encapsulated in the shape memory polymer. 78.The kit of claim 73, further comprising a mold configured to hold thethird solution.
 79. The kit of claim 78, wherein the mold is furtherconfigured to allow the third solution to be polymerized by thepolymerizing device.
 80. The kit of claim 73, further comprising amixing member.
 81. The kit of claim 73, further comprising a firstmetering device.
 82. The kit of claim 81, wherein the first meteringdevice is integrated with the first container.
 83. The kit of claim 81,wherein the first metering device is integrated with the secondcontainer.
 84. The kit of claim 73, further comprising a mixing vessel.85. The kit of claim 84, wherein the mixing vessel is integrated with afirst metering device and the first metering device comprises markings.86. The kit of claim 84, wherein the mixing vessel is capable offunctioning as a mold to define a shape of the third solution while itis polymerized.
 87. The kit of claim 73, further comprising a supportconfigured to hold the cable member partially enveloped by the thirdsolution while the third solution is polymerized by polymerizing device.88. The kit of claim 73, wherein the cable member is selected from ananimal tissue, a synthetic fiber, a natural fiber, a polymer, a metallicwire, a bundle, and a composite.
 89. The kit of claim 88, wherein theanimal tissue is human soft tissue.
 90. The kit of claim 73, wherein themonomer is tert-butyl acrylate.
 91. The kit of claim 73, wherein thecross-linker is polyethylene glycol dimethacrylate.
 92. The kit of claim73, further comprising a photo-initiator.
 93. The kit of claim 92,wherein the photo-initiator is 2,2-dimethoxy-2-phenylacetophenone.
 94. Apolymerized composition comprising: a linear chain comprising anacrylate; and a first cross-linker comprising a multi-functionalacrylate; wherein the polymerized composition exhibits a transition at atemperature between about −50 degrees Celsius and about 150 degreesCelsius; wherein the polymerized composition exhibits shape memoryeffects.
 95. The polymerized composition of claim 94, wherein thepolymerized composition comprises polyethylene glycol and methylmethacrylate.
 96. The polymerized composition of claim 95, wherein thepolymerized composition is polyethylene glycol-methyl methacrylate. 97.The polymerized composition of claim 94, wherein the linear chain isselected from tert-butyl methacrylate, methyl methacrylate, and2-hydroxyethyl methacrylate.
 98. The polymerized composition of claim94, wherein the first cross-linker is selected from polyethylene glycoldimethacrylate, diethylene glycol dimethacrylate, triethylene glycoldimethacrylate and ethylene dimethacrylate.
 99. The polymerizedcomposition of claim 94, comprising a second cross-linker, differentfrom the first cross-linker.
 100. The polymerized composition of claim99, wherein the second cross-linker differs from the first cross-linkerin composition.
 101. The polymerized composition of claim 99, whereinthe second cross-linker differs from the first cross-linker in molecularweight.
 102. The polymerized composition of claim 94, containing morethan about 10% of the weight of the polymerized composition as the firstcross-linker.
 103. The polymerized composition of claim 94, wherein themulti-functional acrylate is di-functional.
 104. The polymerizedcomposition of claim 94, wherein the transition is a glass transition.105. The polymerized composition of claim 94, wherein the transition isa melting point.
 106. The polymerized composition of claim 94, whereinthe polymerized composition exhibits a transition at about 37 degreesCelsius.
 107. The polymerized composition of claim 94, wherein thepolymerized composition exhibits a transition at a temperature betweenabout 34 degrees Celsius and about 50 degrees Celsius.
 108. Apolymerized composition comprising: a first percentage by weight of alinear chain; and a second percentage by weight of a first cross-linker;wherein the polymerized composition exhibits shape memory effects. 109.The polymerized composition of claim 108, wherein the linear chain isselected from tert-butyl methacrylate, methyl methacrylate, and2-hydroxyethyl methacrylate.
 110. The polymerized composition of claim109, wherein the first cross-linker is selected from polyethylene glycoldimethacrylate, diethylene glycol dimethacrylate, triethylene glycoldimethacrylate and ethylene dimethacrylate.
 111. The polymerizedcomposition of claim 108, wherein the second percentage is greater thanabout 10 percent.
 112. The polymerized composition of claim 108, furthercomprising a third percentage by weight of a second cross-linker,different from the first cross-linker.
 113. The polymerized compositionof claim 110, wherein the second cross-linker differs from the firstcross-linker in composition.
 114. The polymerized composition of claim110, wherein the second cross-linker differs from the first cross-linkerin molecular weight.
 115. The polymerized composition of claim 108,wherein the polymerized composition exhibits shape memory effects. 116.The polymerized composition of claim 108, wherein the first cross-linkercomprises polyethylene glycol dimethacrylate.
 117. A surgical methodcomprising: creating a recess in a bone of a patient, the bone having abone temperature; inserting a cable member into the bone; and insertingan implant into the bone, the implant containing a shape memory materialat an insertion temperature different than the bone temperature. 118.The surgical method of claim 117, wherein inserting the implant therebycauses transfer of heat from the bone to the shape memory material. 119.The surgical method of claim 118, wherein the transfer of heat to theshape memory material thereby heats the shape memory material to near atransition temperature of the shape memory material.
 120. The surgicalmethod of claim 118, wherein the transfer of heat to the shape memorymaterial thereby heats the shape memory material to the transitiontemperature of the shape memory material.
 121. The surgical method ofclaim 118, wherein the transfer of heat to the shape memory materialthereby heats the shape memory material to above the transitiontemperature of the shape memory material.
 122. The surgical method ofclaim 117, wherein the inserting the implant is performed along aninsertion axis.
 123. The surgical method of claim 122, wherein insertingthe implant thereby causes the expansion of the shape memory materialalong a transverse axis which is at an angle to the insertion axis. 124.The surgical method of claim 123, wherein the angle is greater than 45degrees.
 125. The surgical method of claim 117, wherein inserting theimplant thereby puts the implant and the cable member into contact. 126.The surgical method of claim 117, wherein inserting the implant therebyapplies a pressure between the implant and a portion of the bone. 127.The surgical method of claim 126, wherein the pressure is transmittedbetween the implant and the bone by the cable member.
 128. The surgicalmethod of claim 117, wherein the implant has a first configuration witha first diameter during insertion and a second configuration with asecond diameter following insertion, the second configuration differentthan the first configuration and the second diameter being larger thanthe first diameter.
 129. The surgical method of claim 128, wherein thefirst configuration has a first generally solid tubular shape having afirst length and the second configuration has a second generally solidtubular shape having a second length shorter than the first length. 130.The surgical method of claim 117, wherein the shape memory material is ashape memory polymer.
 131. The surgical method of claim 130, wherein theshape memory polymer comprises poly-ethylene glycol and poly-methylmethacrylate.
 132. The surgical method of claim 130, wherein the cableis a tendon.
 133. The surgical method of claim 132, wherein the bone isa head of a femur.
 134. The surgical method of claim 117, furthercomprising: contacting the implant with a fluid having a temperaturedifferent than the insertion temperature.
 135. The surgical method ofclaim 117, wherein the recess is a bone tunnel comprising a side walland an end wall and the implant contacts at least a portion of the sidewall when the implant is in the second configuration.
 136. A surgicalmethod for anterior cruciate ligament reconstruction comprising:creating a bone tunnel in a head of a femur of a patient, the bonehaving a bone temperature; inserting a connective tissue into the bonetunnel; and inserting a shape memory polymer plug into the bone tunnelwherein the plug has a first configuration for insertion and a secondconfiguration for affixation, the second configuration comprising aradially expanded dimension that presses the connective tissue against aside wall of the bone tunnel such that the connective tissue becomesaffixed in the bone tunnel and wherein the plug changes from the firstconfiguration to the second configuration based on an activationtemperature equal to or greater than the bone temperature.
 137. Thesurgical method of claim 136, wherein the bone tunnel temperature is anaverage temperature of the human body.
 138. The surgical method of claim137, wherein the tissue is a part of a hamstring tendon of the patient.139. The method of claim 54, wherein the activating is heating, andwherein the heating comprises a transfer of heat from the bone to theshape memory material.
 140. The method of claim 54, wherein theactivating is heating, and wherein the heating comprises flooding theretention device with a liquid bath.
 141. The method of claim 54,wherein the activating is heating, and wherein the heating comprises atransfer of heat from the bone to the shape memory material, andflooding the retention device with a liquid bath.